Topic Contents

Biologics for Inflammatory Bowel Disease

Examples

Generic Name

Brand Name

adalimumab

Humira

certolizumab

Cimzia

golimumab

Simponi

infliximab

Remicade

natalizumab

Tysabri

How It Works

These medicines stop a
protein that increases inflammation in the body. They block the inflammatory response that happens in
Crohn's disease and
ulcerative colitis. They are given as a shot.
Infliximab and natalizumab are given as a shot in a vein (intravenous, or IV). Adalimumab, certolizumab, and golimumab are
given as a shot under the skin (subcutaneous).

Why It Is Used

These medicines are used to start remission (a period without symptoms) in people who have Crohn's disease or ulcerative colitis. They are also used to help someone stay in remission.

These medicines are usually used when the disease doesn't get better with other medicines. They may also be used in people who cannot take other medicines.

Infliximab may also be used to treat
abnormal connections (fistulas) between the intestines and
organs in moderate-to-severe Crohn's disease.

How Well It Works

Crohn's disease

In multiple studies, almost 70 out of
100 people taking infliximab had fewer symptoms or had healed fistulas.1

Adalimumab has shown promise in treating Crohn's
disease in multiple studies.2 It works like infliximab
and may be good for people who are allergic to infliximab.

Certolizumab works in some people to stop the symptoms of Crohn's
disease. In these people, certolizumab works well to help keep them free of
symptoms (in remission).3, 4

Studies show that natalizumab works to stop the
symptoms Crohn's disease in some people and to keep some people free of
symptoms. But natalizumab may cause a serious and life-threatening disease
called PML. Because of this risk, natalizumab is only available through a
special prescription drug program.5

Ulcerative colitis

In one study, between 60 and
70 out of 100 people with ulcerative colitis were better 8 weeks after getting
infliximab treatment. In another study, twice as many people got better after
receiving infliximab compared to those taking a placebo.6

In one study, almost 20 out of 100 people with ulcerative colitis were better after 8 weeks of using adalimumab.7 This drug hasn't been studied as much for ulcerative colitis compared to other medicines. Doctors still don't know a lot about how well it works.

Side Effects

All medicines have side effects. But many people don't feel the side effects, or they are able to deal with them. Ask your pharmacist about the side effects of each medicine you take. Side effects are also listed in the information that comes with your medicine.

Here are some important things to think about:

Usually the benefits of the medicine are more important than any minor side effects.

Side effects may go away after you take the medicine for a while.

If side effects still bother you and you wonder if you should keep taking the medicine, call your doctor. He or she may be able to lower your dose or change your medicine. Do not suddenly quit taking your medicine unless your doctor tells you to.

Call 911 or other emergency services right away if you have:

Trouble breathing.

Swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have:

Hives.

Signs of illness or infection, such as chills, cough, or fever.

Chest pain or tightness.

A rash on your head, face, or belly.

Belly pain or fullness.

Lower back or side pain, especially with painful urination.

Common side effects of this medicine include:

Stomach pain, nausea, and vomiting.

Painful throat.

Redness, itching, or swelling at the injection site.

Skin problems, such as bleeding, blistering, or crusting.

What To Think About

Drug safety

Warnings about serious side effects of biologics have
been issued. The U.S. Food and Drug Administration (FDA) and the drug's
manufacturers have warned about:

An increased risk of a serious infection. Biologics affect
the body's ability to fight all infections. So if you get a fever, cold, or
the flu while you are taking this medicine, let your doctor know right
away.

An increased risk of blood or nervous system disorders. Call
your doctor if you have symptoms of blood disorders (such as bruising or
bleeding) or symptoms of nervous system problems (such as numbness, weakness,
tingling, or vision problems).

An increased risk of lymphoma (a type of blood cancer) in children and adolescents who take this medicine for longer than 2½ years (30 months). Adults, children, and adolescents who take this medicine also have a higher risk for leukemia and other cancers.

An increased risk of liver injuries.
Call your doctor if your skin starts to look yellow, if you are very tired, or
if you have a fever or dark brown urine.

In very few cases, natalizumab has caused a serious and
life-threatening brain infection called PML (progressive multifocal leukoencephalopathy). Natalizumab is tightly controlled because
of this. If you take natalizumab, you will need to enroll in a program called
the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD-TOUCH)
Prescribing Program.

Your risk for getting PML increases if you have any of these risk factors:

You have been taking natalizumab for longer than 2 years.

You have taken other immunosuppressant medicines, such as methotrexate or cyclophosphamide.

You have ever been infected with the JC virus. There is a test your doctor can do to see if you have antibodies to the JC virus in your blood.

Taking medicine

Medicine is one of the many tools your doctor has to treat a health problem. Taking medicine as your doctor suggests will improve your health and may prevent future problems. If you don't take your medicines properly, you may be putting your health (and perhaps your life) at risk.

There are many reasons why people have trouble taking their medicine. But in most cases, there is something you can do. For suggestions on how to work around common problems, see the topic Taking Medicines as Prescribed.

Advice for women

If you are pregnant, breast-feeding, or planning to get pregnant, do not use any medicines unless your doctor tells you to. Some medicines can harm your baby. This includes prescription and over-the-counter medicines, vitamins, herbs, and supplements. And make sure that all your doctors know that you are pregnant, breast-feeding, or planning to get pregnant.

Checkups

Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems. It's also a good idea to know your test results and keep a list of the medicines you take.

References

Citations

American Gastroenterological Association (2007).
American Gastroenterological Association consensus development conference on
the use of biologics in the treatment of inflammatory bowel disease.
Gastroenterology, 133(1): 312–339.

American Gastroenterological Association (2007).
American Gastroenterological Association consensus development conference on
the use of biologics in the treatment of inflammatory bowel disease.
Gastroenterology, 133(1): 312–339.

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